30 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OEC 9800 PLUS
FDA 510(k)
FDA Class 2
·Radiology
NexxZr™ T / D-100-18-NT-A300-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271112378·
Baby Gorilla/Gorilla Plating System
FDA UDI
Paragon 28, Inc.·00889795145444·Ovr Dr Gd, Dbl End, 2.0/2.7mm, R3CON
Baby Gorilla/Gorilla Plating System
FDA UDI
Paragon 28, Inc.·00889795145451·Drill Guide Sleeve, 2.7mm, R3CON
CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ASTOTUBE®
FDA Adverse Event
Malfunction
·STIHLER ELECTRONIC GMBH·Product code BSB·August 7, 2025
BIVONA SILICONE TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·February 7, 2024
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·December 23, 2025
CLEARLINK/CONTINU-FLO/DUO-VENT
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 22, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·October 1, 2014
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
FDA Recall
Terminated
·Zimmer Dental Inc·Product code DZE·January 6, 2014
CLEARLINK/CONTINU-FLO/DUO-VENT
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 8, 2025
CLEARLINK/CONTINU-FLO/DUO-VENT
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 22, 2025
VANGUARD CEMENTED PS OPEN BOX FEMORAL -RIGHT 67.5 MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code JWH·May 4, 2017
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·February 5, 2014